The Viveve® System is an internationally patented cryogen-cooled, monopolar radiofrequency (CMRF) based device. It has received regulatory approval in many countries throughout the world and is available through physician import license in Japan. Country-specific approved indications include:
· In Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Hong Kong, Japan, Malaysia, Panama, Philippines, Singapore and the UAE the Viveve System is approved for the treatment of the vaginal introitus, after vaginal childbirth, to improve sexual function.
· In the EU, Iceland, Korea, Lebanon, Liechtenstein, Norway, Switzerland and Turkey the Viveve System is approved for the treatment of vaginal laxity.
· In Thailand and the United States the Viveve System is cleared for general surgical procedures for electrocoagulation and hemostasis.